2. Design/ Reliability/ Quality/ Manufacturing/ Matls Eng Decision Tree (Common Checklist) for mproc this section wil be signed by a quality representative.
. Note: If change impacts a component or product that is used in a drug device combination product, this review must be completed and signed by Pharma Quality Assurance. When the component or product is used in a drug device combination product, the Quality signatures are to be filled in by Pharma Quality.)
A
General Section (A)
(Affecting finished product, subassembly, components or raw materials)
A1
Yes
No
Change as a result of one of the following:
Medical Device Reporting (MDR), vigilance report or equivalent
External regulatory body audit finding or Warning Letter (NOT an improvement suggestion)
Field-related CAPA
Field action
A2
Yes
No
Finished product change visible to end customers (physicians, clinicians, or patients)
A3
Yes
No
Change to design facility name (including change in ownership) or location (including OEM or contract manufacturing facilities)
A4
Yes
No
Change to a manufacturing facility name or location that is visible on finished product labeling
manufacturing facility name of finished product mfg, OEM, contract manufacturer
manufacturing facility location of finished product mfg, OEM, contract manufacturer
manufacturing facility name of test laboratory
manufacturing facility location of test laboratory
manufacturing facility name of supplier
manufacturing facility location of supplier
A5
Yes
No
Change to a manufacturing facility name or location that is not visible on finished product labeling
manufacturing facility name of finished product mfg, OEM, contract manufacturer
manufacturing facility location of finished product mfg, OEM, contract manufacturer
manufacturing facility name of test laboratory
manufacturing facility location of test laboratory
manufacturing facility name of supplier
manufacturing facility location of supplier
A6
Intentionally left blank to align with Corporate Policy 043-P010
A7
Yes
No
Change to stability protocol (as an extension/modification to the product expiration).
A8
Yes
No
Change to product’s Universal Product Number (UPN).
If one or more questions are answered “Yes” in General Section (A), completing the Exceptions List Section (EX) is not required. Proceed and complete Detailed Section Zero (Z).
If all questions are “No” in General Section (A), proceed and complete the Exceptions List Section (EX).
EX
Exceptions List Section (EX)
If the exception applies, mark “Yes”. Section EX has no bearing on whether notification is required or not; whether you have a “Yes” in Sections A through K determines whether notification is required. Section EX identifies potential reasons not to notify.
EX1
Yes
No
Formatting, Layout and Obvious Errors
The following exceptions do NOT require notification:
Change to the revision of a part or document where there is no change to technical content (e.g. changing the revision of a part in order to keep revisions synchronized for “sister documents” or for product family)
Change to document layout and/or document ownership, correction of a typographical error, spelling, punctuation, or obvious errors that do not change the intent or technical content
Combining two procedures/process/work instructions into one where there is no addition or deletion of the technical content in the revised document and/or when there is no change to the sequence of operations within the work-steps
Redrawing or reformatting where there is no change to the product, process or component
Translating a document from one language to another where the content of the translated document remains the same
Add, eliminate or move logo or trademark/copyright symbols
Moving a manufacturing instruction from one type of document to another where the instruction has not changed (i.e. identical verbiage) and the process has not moved in the manufacturing flow (e.g., moving a manufacturing instruction from an engineering drawing to a process instruction with no change to the content)
EX2
Yes
No
Non-Process Changes
The following exceptions do NOT require notification:
Change modifying the release date of a change order (for example. ECO or DCR)
Change Nomenclature (e.g. supplier is re-naming component) when there is no change to the component and the nomenclature is not included in any regulatory submission
Changes to in-house tracking methods or other systems used for collection of manufacturing-related data (e.g. trace sheets, operator certifications/qualifications, and other items not included on the lot history record). This change must not include changes to systems used as part of the manufacturing process flow.
Add/delete/change a non-process instruction, note, table, figure or diagram. This change must not affect manufacturing, inspection, or process flow.
EX3
Yes
No
Reference Documents
The following exceptions do NOT require notification:
Addition/deletion/correction of a reference document, provided that it does not alter test methods, product, processes, components or any claims of compliance to a corporate and/or external standard.
Proceed and complete Detailed Section Zero (Z).
Z
Detailed Section Zero (Z)
B0
Yes
No
Change that could impact manufacturing, refer to Manufacturing Change Section (B).
C0
Yes
No
Change that could impact sterilization, refer to Sterilization Change Section (C).
D0
Yes
No
Change that could impact labeling, refer to Labeling Change Section (D).
E0
Yes
No
Change that could impact design, refer to Design Change Section (E).
F0
Yes
No
Change that could impact change in a material, refer to Change in a Material Section (F).
G0
Yes
No
Change that could involve a different supplier, refer to Change to a Different Supplier Section (G).
Note: Answer “Yes” for same supplier, new commodity.
Note: See applicable manufacturing, design, etc sections for those types of changes at an existing supplier.
H0
Intentionally left blank to align with Corporate Policy 043-P010
I0
Intentionally left blank to align with Corporate Policy 043-P010
J0
Yes
No
Change that could impactfinished product, subassembly, or component’s telemetry, refer to Radio Regulatory Change Section (J).
K0
Yes
No
Change that could impactIT systems, refer to Information Technology (IT) System Change Section (K).
Note: Answer “No” if change does not occur at a Medtronic or VIS Facility.
For each question answered “Yes” in Detailed Section Zero (Z), proceed and complete all of the applicable questions in the Referenced Sections. For each question answered “”No” in Detailed Section Zero (Z), the applicable questions in the Referenced Sections should be skipped and left blank.
If all questions in Detailed Section Zero (Z), are answered “No”, proceed to the instructions following Section (K)-Information Technology (IT) System Change.
B
Manufacturing Change Section (B)
(Affecting finished product, subassembly, components or raw materials)
B1
Yes
No
Manufacturing process-related: Addition, removal, or re-sequence or modification of manufacturing work steps, such as:
Modified cleaning or packaging work steps
Adding or modifying a rework step(s)
Modified work instructions that impact the following areas:
Technical content including rework
Monitoring (that impact decision to move to the next process step)
If any of the following exceptions apply, check “No” for this question:
Removing rework step(s)
B2
Yes
No
Inspection or test-related: Addition, removal, re-sequence (change in test or process flow), movement to an alternate inspection/test facility, or any modification of quality inspection procedures or acceptance criteria, such as:
Incoming inspection
In-process inspection
Final inspection
Sampling/frequency changes
Electrical test
Change to test method (new method or modification to existing method)
Change to test limits or acceptance criteria outside the qualified limits or criteria
Change to technical content including changes based on a new or revised standard
If any of the following exceptions apply, check “No” for this question:
Obsolete a test method or inspection that is no longer used including removal of test method or inspections that were for information gathering only.
Change to test limits or acceptance criteria within the qualified limits or criteria
A change of an inspection or test to a different sequence than is currently performed which was previously qualified or specified that order does not matter.
Wording or picture changes or additions that are made to clarify existing content that don’t change the technical content or intent. Example: language translation purposes.
B3
Yes
No
Manufacturing process change: Addition, removal, or change to manufacturing process that requires testing such as component qualification, process qualification (OQ), process validation (PQ), or Installation qualification (IQ or EIQ).
For changes requiring only installation qualification (IQ or EIQ), answer “No” here but refer also to B6a.
B4
Yes
No
Manufacturing specifications/requirements: Specifications/requirements change outside existing qualified tolerances/parameters/limits/window (not the characterized window), regardless of whether it is considered critical or not.
B5
Yes
No
Manufacturing method or technology: For example: change from manual to automated process or vice versa; or change from machined to stamped technology or vice versa.
B6
Yes
No
Software: Adding, deleting or modifying software.
Examples: Inspection software, test software, or equipment software.
For changes to manufacturing or quality control systems answer “No” here and refer to Section K.
If any of the following exceptions apply, check “No” for this question:
Change to software configuration, such as changes to turn on or modify functionality that is already available/qualified in the released software
Change to turn on or modify software parameters so that equipment is within the originally qualified outputs. Examples would be listed in original qualification.
Parameter or function changes made within already approved software (for example: changing font, color, or user interface).
Application of service packs, security patches, anti-virus software/updates for operating system
Equipment, tooling/fixture, processing aid: Addition or change to equipment, such as:
Equipment controllers
Test equipment
Tooling/fixture
Manufacturing or processing aids
Calibration frequency or method (only if related or used in special processes)
If any of the following exceptions apply, check “No” for this question (Not applicable for special processes):
Change that requires IQ or EIQ only
Change that does not require component qualification, OQ and/or PQ
Removal of duplicate or equivalent equipment, tooling/fixture, or processing aid
Addition of duplicate(s) or equivalent. For changes to a different brand, model, or print/specification/drawing, notification is NOT required if change is equivalent with no significant different attributes, and equivalency is documented and approved.
Document changes (e.g. new part number) to manufacturing tools or other processing aids which do not alter the dimensions, specifications, intent, or functionality of the tool.
B7
Yes
No
Environmental change: Change that impacts environmental specifications or conditions including environmental equipment used for or affecting finished products, subassemblies, components, or raw materials including
manufacturing areas
inspection areas
testing areas
storage areas
If any of the following exceptions apply, check “No” for this question:
Normal maintenance of the environmental area (Example: changing a HEPA filter or changing chart recorder paper).
B8
Intentionally left blank to align with Corporate Policy 043-P010
B9
Yes
No
Test method: Change to test method that could impact validity of the existing design verification, design validation, or design assurance (DAU) testing
B10
Yes
No
Subassembly, component, or raw material: If you answered yes to any of the B1 to B9 changes and the change was at subassembly, component or raw material level, mark “Yes” in B10. If the change was at the final device level, then mark “No” in B10.
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
C
Sterilization Section (C)
(Affecting finished product, sub assembly, components or raw materials)
C1
Yes
No
Addition, removal, or modification to sterilization process parameters such as: pre-sterilization and post-sterilization processing (for example: aeration), changing frequency/monitoring, or changing load configuration
C2
Yes
No
Change or modification to sterilization equipment such as: calibration, sterilization room/environment, change to software, relocation of equipment, or addition of new equipment
C3
Yes
No
Change or modification to sterilization method (for example: Radiation to EtO)
C4
Yes
No
Change that requires sterilization validation or revalidation
C5
Yes
No
Change to sterilization facility name or location
C6
Yes
No
Change to specifications, requirements, or parameters associated with sterilization or changes to EtO Inspection Procedure (IP)
C7
Yes
No
Material change that impacts sterilization including changes to supplier of sterilant or use of different sterilant supplied by the same supplier (for example: release specifications for drug used in product).
C8
Yes
No
Change related to revised or new standard that impacts sterilization (for example: change to ISO standard)
C9
Yes
No
Is there a change that increases the bioburden alert or action levels or that introduces a more difficult to kill organism?
C10
Yes
No
Is there a device design or material change that introduces a more difficult to sterilize feature?
C11
Yes
No
Is a change made from a nonparametric release to a parametric release?
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
D
Labeling Section (D)
(Affecting final distributed product, for example: outer package, engraving, sterile pack, lead labels, manuals, instructions and inserts)
D1
Yes
No
Change to product name, product model, or product number
D2
Intentionally left blank to align with Corporate Policy 043-P010
D3
Yes
No
Change to indication/intended use, warnings, precautions, or contraindications
D4
Yes
No
Change to product label content (for example: additions, deletions, text changes, font changes for warnings and precautions, text converted to symbols and vice versa, Representative name or address on packaging change, country of origin)
D5
Yes
No
Change to product label format or additional languages
D6
Yes
No
Change to product manual content (for example: additions, deletions, text changes, font changes for warnings and precautions, text converted to symbols and vice versa, Representative name or address change on packaging, country of origin)
D7
Yes
No
Change to product manual format or addition of new languages/translations that does not impact technical content
D7b
Yes
No
Change to product manual format or addition of new languages/translations that does impact technical content or change in media from paper to emanual or another type of medium.
D8
Yes
No
Change to symbols listed on product label or manual
D9
Yes
No
Change to labeled shelf life of product
D10
Yes
No
Change to label material
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
E
Design Section (E)
(Affecting finished product, sub assembly, components or raw materials)
E1
Yes
No
Change to design of a finished device including dimensional/tolerance changes
E2
Yes
No
Change to design of a subassembly, component, or raw material including dimensional/tolerance changes
E3
Yes
No
Change to design of finished product primary packaging or secondary packaging
Primary packaging: sterile barrier or innermost package, defined in CSS.1504.XXXX-0040 as package that contains device and associated accessories (for example: sterile pack for sterile device)
Secondary packaging: packaging other than primary packaging, defined in CSS.1504.XXXX-0040 as the package that contains the devices, accessories, and accompanying documentation and in which the device is stored by user prior to (or when not in) use
E4
Intentionally left blank to align with Corporate Policy 043-P010
E5
Yes
No
Change to accessories packaged with a device/finished product
E5b
Yes
No
For IT system related to packaging refer to the Section “IT: Information Technology (IT) System
E6
Yes
No
Change to product design/performance specifications or requirements for finished product
E7
Yes
No
Change to product design/performance specifications or requirements for subassembly, component, or raw material
E8
Yes
No
Change to test method that could impact validity of existing design verification, design validation, or design assurance (DAU) testing
E9
Yes
No
Change that requires re-testing (verification, validation or qualification) of finished device design
E10
Yes
No
Change that requires re-testing (verification, validation or qualification) of subassembly, component, or raw material
E11
Yes
No
Change to finished device software or firmware that changes the diagnosis, treatment, or therapy
Software or firmware change which impacts the control of the device, that may alter the diagnosis or therapy delivered to the patient
Software or firmware change that modifies an algorithm impacting the diagnosis or therapy delivered;
Software or firmware change that impacts the way data is read or interpreted by the user, such that the treatment or diagnosis of the patient may be altered when compared to the previous version of the software
Software or firmware change that replaces previously required user input a closed loop decision
Software or firmware change that adds a new feature that may change the diagnosis or therapy delivered to the patient
Software or firmware change introduction to or removal of a new alarm function from the software such that a response to the new configuration may change the treatment of the patient in comparison to the previous version of the software
Update to software revision that is triggered by addition of model(s) which may not be marketed in particular countries. This can occur when a software model is shared by multiple products.
E12
Yes
No
Change to finished device software or firmware that does NOT change the therapy
E13
Yes
No
Change related to revised or new standard that impacts design (for example: change to ISO or ASTM standard)
E14
Yes
No
Software change that that incorporates a change to the operating system on which the software runs.
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
F
Change in a Material Section (F)
(Affecting finished product, subassembly, or component, or raw materials)
F1
Yes
No
Change to material and/or material specification of a blood/tissue contacting component
F2
Yes
No
Change to material and/or material specification of NON-blood/tissue contacting component
F3
Yes
No
Change that adds or alters materials associated with manufacturing or packaging process (for example: cleaning materials, processing aids, etc.)
F4
Yes
No
For biological/animal origin or tissue/blood contactingmaterials: any change to material specification, formulation, trade/brand name, or material standard
F5
Yes
No
Change to active pharmaceutical ingredient (API) or excipient
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
G
Change to a Different Supplier Section (G)
(Affecting finished product, subassembly, or component, or raw materials)
Note: A supplier is considered different if they currently do not perform the specific “operation” even if they are currently a qualified supplier to Medtronic.
Note: A change in distributor would require notification if the finished product, subassembly, component, or raw material is changed. Those changes should also be captured in the appropriate section (manufacturing process change, design change, material change, etc). If only the distributor is changed, and there is no change in the finished product, subassembly, component, or raw material, answer “No”.
Note: For changes at an existing supplier, see sections B and E.
G1
Yes
No
Change to different supplier of a finished product subassembly, component, or raw material
G2
Yes
No
Change to different supplier of a packaging component
G3
Yes
No
Change to different supplier of a biological/animal origin subassembly, component, or raw material
G4
Yes
No
Change to different supplier of a tissue/blood contacting subassembly, component, or raw material
G5
Yes
No
Change to different supplier of a subassembly, component, or raw material that is NOT of biological/animal origin and NOT tissue/blood contacting
Change to different supplier/manufacturerwhere inspection does NOT take place at Medtronic (for example: test labs or suppliers of materials, components, subassemblies, contract design facilities)
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
H
Safety and Performance (H)
H1
Intentionally left blank to align with Corporate Policy 043-P010
H2
Intentionally left blank to align with Corporate Policy 043-P010
H3
Intentionally left blank to align with Corporate Policy 043-P010
I
Japan (I)
I1
Intentionally left blank to align with Corporate Policy 043-P010
I2
Intentionally left blank to align with Corporate Policy 043-P010
J
Radio Regulatory Change Section (J)
(Affecting products that have telemetry)
J1
Yes
No
Change to software that impacts Radio Frequency (RF) properties (for example: data rate, RF power output, or bandwidth)
J2
Yes
No
Change to oscillators, voltage controlled oscillator circuits, or RF frequency generating crystals
J3
Yes
No
Change in antenna (for example: size or shape)
J4
Yes
No
Change in printed circuit board (PCB) layout that affects RF performance
J5
Yes
No
Change in device housing cabinet, in cases where it has RF/ electromagnetic interference (EMI) shielding properties
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
K
Information Technology (IT) System Change Section (K)
(Affecting IT System only at Medtronic owned facilities, including vertically integrated suppliers [VIS])
If the Answer is “Yes” for any of the following exceptions, Answer “No” in Detailed Section Zero (Z) above for impact to IT Systems and do NOT complete this section; otherwise continue below as instructed.
IT System exceptions that do NOT require notification:
Change to software configuration, such as changes to turn on or modify functionality that are already available/qualified in the released software.
Change to turn on or modify software parameters so that equipment is within the originally qualified outputs. Examples would be listed in original qualification.
Parameter or function changes made within already approved software (for example: changing font, color, or user interface)
Changes to document and change control management software
Operating system upgrades
Application of service packs, security patches, Anti-virus software/updates for operating system
Changes to software that documents equipment calibration, repair and maintenance
K1
Yes
No
Change to IT System that directly affects labeling finished product, subassembly, or components
K2
Yes
No
Change to IT System that directly affects packaging finished product, subassembly, or components
K3
Yes
No
Change to IT System that performs automatic disposition of materials
K4
Yes
No
Change to IT System that is the primary source of device history record/manufacturing traceability
NOTE: Device History Record (DHR) is a compilation of records containing the production history of a finished device.
K5
Yes
No
Change to IT System that directly affects manufacturing of finished product, subassembly, component, or raw materials. Includes processing, inspection, monitoring, quality control (e.g. strength, durability, identity, efficacy, reliability, purity, or sterility), manufacturing control, product testing and release.
K6
Yes
No
Change to IT System that directly affects forward moving interplant product or component transfer through manufacturing (supplier to final device facilities, does not include returns back to originator).
In scope example: MMC (Promis) components/subassemblies to JDE to final device facility (FACTORYworks).
Out of scope example: returning product from final device manufacturer to supplier.
K7
Yes
No
Change to IT System that directly affects environmental controls in manufacturing, storage, or testing.
K8
Yes
No
Change to IT System that corrects an issue in currently released system but does NOT add or modify any other areas of the system (software corrected to meet established requirements or original intent of requirements)
K9
Yes
No
Change to IT System Software that automates a manual manufacturing process.
Example: IT System Software that makes automated decision for equipment calibration status that was previously done manually by operator/supervisor.
Answer any additional Referenced Sections that were identified in Detailed Section Zero (Z) above.
A Quality Representative must approve below stating agreement with the completion of the above information (General, Change Detail Information, and Decision Tree/ Common Checklist)
The Quality Representative needs to complete and sign section 6.
If all questions in sections A through K are “No”, then complete Sections 1 & 6 as needed ensuring at least two different signatures, and Sections 3, 4 and 5 are not required.
If one or more questions listed in Section A or in Sections B through K are marked “Yes”, then Sections 3 and 4 are required for CRDM, Neuromodulation, Diabetes and Surgical Technologies. For Spinal BU complete section 5. (section 3 and 4 are not required).
NOTE: Approvals on section 3, 4 and 5 are only for Regulatory/Reliability and in the case of Spinal for BU approving functions stated in GQ121.
NOTE: The answers to questions in Section Z are used to determine potential impacts only and have no bearing on notification individually.
For Villalba Facility ONLY:
Notify to the designated Quality Engineer to register the change in the Reliability and
Regulatory Approval Process Change Tracking System.
